Isolation of Pulmonary Veins With PVAC GOLD in Elderly Patients

NCT04023461 | Completed Phase 4

• 1 other identifier: 4471/16/137
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

It is a prospective, randomized and double-blind clinical trial involving an invasive technique for isolation of pulmonary veins (PVAC gold) in relation to clinical treatment during an one year of segment. The patients included have paroxysmal atrial fibrillation (aged 65 years and older) refractory to antiarrhythmic treatments that do not have structural and / or ischemic heart diseases. This trial employed quality of life scores prior to the study and during the sixth and twelfth month of the segment, electrocardiograms and holter of 24 hours. The proposed imaging tests was the transesophageal echocardiogram before each procedure. The cerebral MRI was performed in the 24 hours post invasive procedure and Angio-tomography of the pulmonary veins in the 6-month segment.

Conditions

Atrial Fibrillation Paroxysmal; Cardiac Arrythmias

Keywords

Radiofrequency Ablation; Atrial Fibrilation; PVAC GOLD catheter; Elderly patients

Outcome Measures

Primary Outcomes (1)

• Recurrence of atrial fibrillation

  Recurrence of atrial fibrillation during 1 year of follow-up

  1 year after ablation

Secondary Outcomes (3)

• Occurrence of Asymptomatic Cerebral Embolism

  1 year of follow-up

• Esophageal Ulcer

  24 hours after pulmonary vein isolation

• Quality of Life Assessment

  1 year after ablation

Study Arms (2)

Clinical Treatment Group

NO INTERVENTION

Interventional Ablation Group

EXPERIMENTAL

Device: PVAC GOLD catheter ablation

Interventions

PVAC GOLD catheter ablation DEVICE

Isolation of pulmonary veins using PVAC GOLD catheter.

Interventional Ablation Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Indication for isolation of pulmonary veins
• Age \>= 65 years old
• Association with the following characteristics:
• Symptomatic Atrial Fibrillation;
• Sinusal Rhythm maintenance failure for at least 1 Antiarrythmic Drugs;
• Diagnosis of Atrial Fibrilation on resting eletrocardiogram and/or 24h Holter.

You may not qualify if:

• Prior Atrial Fibrillation ablation;
• Atrial Fibrillation permanent and/or persistent;
• Left atrial size \> 55 mm;
• Mechanical prothetic mitral valve replacement;
• Presence of atrial thrombus;
• Cardiac invasive procedure \< 90 days;
• Cerebral embolism \< 6 months;
• Hypertrophic cardiomyopathy;
• Contraindications to antiocoagulation and cerebral MRI.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Medtronic: collaborator

Study Sites (1)

Arrhythmia Clinical Unit - Instituto do Coração - HCFMUSP

São Paulo, São Paulo, 05403010, Brazil

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mauricio I Scanavacca, MD, PhD

  Arrythmia Clinical Unit Director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: At the time of patient recruitment, they were randomly assigned to ablation or medical therapy (antiarrhythmic drug arm) according to a 1:1 stratified randomization list locked into a computer system.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Arrhythmia Clinical Unit Director

Model Details: All patients in clinical treatment arm had to keep on antiarrhythmic drug for AF rhythm control strategy

Study Record Dates

• First Submitted: July 15, 2019
• First Posted: July 17, 2019
• Study Start: June 29, 2017
• Primary Completion: February 20, 2021
• Study Completion: June 3, 2022
• Last Updated: July 12, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)